Senior Quality Assurance Engineer

Coalesce Management Consulting; Singapore; On-site; SGD 60,000 - 100,000; Full time

Job summary

Coalesce Management Consulting seeks a Quality Assurance Engineer to support pharmaceutical manufacturing operations with a strong focus on CQV, equipment qualification and GMP compliance. The role involves hands-on qualification on the manufacturing floor and thorough review of documentation to ensure processes operate as intended.

You will provide QA oversight across equipment, facilities and utilities lifecycle, perform IQ/OQ/PQ activities, assess deviations and CAPA, and collaborate with

Qualifications

• CQV and validation lifecycle knowledge.
• Hands-on IQ/OQ/PQ execution experience.
• Experience reviewing validation documentation from QA/engineering perspectives.
• Knowledge of cleaning validation in manufacturing.
• Understanding GMP requirements and regulatory expectations.

Responsibilities

• Provide QA oversight for CQV activities in GMP environments.
• Review IQ/OQ/PQ protocols and reports.
• Perform hands-on equipment qualification activities.
• Support commissioning and qualification activities including validation and equipment release.
• Review deviations, CAPA, change controls and validation discrepancies.
• Support qualification of equipment, facilities and utilities.
• Maintain inspection-ready validation documentation for regulatory inspections.
• Collaborate with Engineering, CQV, Validation, Manufacturing and Operations.

Skills

CQV

Equipment qualification

GMP compliance

IQ/OQ/PQ

Technical writing

Analytical

Problem-solving

Cross-functional collaboration

Education

Degree in Engineering/Life Sciences or related

Job description

We are seeking a Quality Assurance Engineer to support pharmaceutical and biopharmaceutical manufacturing operations and project activities, with a strong focus on Commissioning, Qualification and Validation (CQV), equipment qualification and GMP compliance.

The successful candidate will provide Quality oversight across the lifecycle of manufacturing equipment, facilities and utilities, while also supporting hands-on qualification and validation activities. The role requires someone who is technically strong, comfortable working on the manufacturing floor, and able to review documentation while understanding how equipment and processes operate in practice.

Key Responsibilities

• Provide QA oversight and support for Commissioning, Qualification and Validation (CQV) activities within a GMP-regulated pharmaceutical or biopharmaceutical environment.
• Review and approve qualification and validation documentation, including IQ, OQ and PQ protocols and reports, risk assessments and supporting technical documentation.
• Perform and support hands-on equipment qualification activities for project and operational equipment.
• Support commissioning and qualification activities including FAT, SAT, commissioning, IQ/OQ/PQ and equipment release.
• Review and assess deviations, CAPA, change controls and validation discrepancies, ensuring appropriate investigation and closure.
• Support qualification of manufacturing equipment, facilities and utilities such as bioreactors, autoclaves, process equipment, HVAC, WFI and associated systems.
• Provide QA oversight for equipment maintenance, calibration and qualification status to ensure continued GMP compliance.
• Support cleaning validation activities for routine manufacturing operations, including protocol/report review, execution support, periodic requalification and investigation of cleaning-related issues.
• Review GMP documentation to ensure compliance with approved procedures, regulatory requirements and internal quality standards.
• Work closely with Engineering, CQV, Validation, Manufacturing and Operations teams to ensure quality requirements are incorporated throughout project execution.
• Support validation-related investigations and determine the potential impact of equipment, process or system changes on validated status.Maintain inspection-ready validation and qualification documentation and support regulatory inspections and internal/external audits where required.
• Provide Quality input during commissioning and start-up of new or modified manufacturing equipment and systems.

Requirements

• Degree in Engineering, Pharmaceutical Science, Biotechnology, Life Sciences or a related technical discipline.
• Relevant experience within a pharmaceutical, biopharmaceutical or GMP-regulated manufacturing environment.
• Strong knowledge and practical experience in CQV and equipment qualification.
• Hands-on experience executing or supporting IQ/OQ/PQ activities for manufacturing equipment.
• Good understanding of GMP requirements, validation lifecycle principles, deviations, CAPA and change control.
• Experience reviewing technical and validation documentation and the ability to assess documentation from both a Quality and engineering perspective.
• Knowledge and practical exposure to cleaning validation, particularly for routine manufacturing operations.
• Understanding of equipment calibration, preventive maintenance and continued qualified state.
• Strong technical writing, analytical and problem-solving skills.
• Ability to work effectively with Engineering, Operations, Validation and other cross-functional stakeholders.